GENERICally Speaking Hatch Waxman Bulletin

The Second quarter issue of the GENERICally Speaking campaign provides you and your company with some of the knowledge beneficial to remaining attentive to the complexity of ANDA patent litigation.

In this issue:

• Vanda Pharms. Inc. v. Teva Pharms. USA, Inc.
  Hetlioz® (tasimelteon)
  Appellate court affirms trial court’s invalidty ruling, holding that the trial court did not err in finding an expectation of success and that the claimed invention was “obvious to try.”
• Amgen Inc. v. Sandoz Inc.
  Otezla® (apremilast)
  Crediting expert testimony, the district court did not err in finding two of the asserted patents claiming solid forms and pharmaceutical compositions of apremilast not invalid as obvious, and a third asserted patent claim a method of treatment invalid as obvious.
• UCB, Inc. v. Actavis Labs. UT, Inc.
  Neupro® (rotigotine)
  The district court erred in its anticipation analysis as it related to prior art ranges, but did not err in its obviousness analysis, which was affirmed.
• Sanofi-Aventis U.S. LLC v. Sandoz, Inc.
  Jevtana® (cabazitaxel)
  The trial court held the patent-in-suit infringed on the basis of the teaching of defendant’s label, and not invalid as obvious because a skilled artisan would not have had a reasonable expectation of success in the prior art combination of record.
• In re Sugammadex
  Bridion® (sugammadex sodium)
  Because the Patent Act requires a patent term extension of a reissued patent to be calculated based on the issue date of the original patent, the reissued patent’s five-year PTE term was not invalid.
• Astellas Pharma Inc. v. Sandoz Inc.
  Myrbetriq® (mirabegron)
  In defending against a claim of non-enablement, plaintiff concedes that the patent specification describes well known, routine, and conventional methods for the claimed invention thus rendering the claims invalid under Section 101.
• Janssen Pharms., Inc. v. Mylan Labs. Ltd.
  Invega Trinza® (paliperidone palmitate)
  The court found the patent-in-suit infringed, over Defendant’s divided infringement defense, and not invalid, in spite of Defendant’s obviousness and Section 112 defenses.
• Azurity Pharms., Inc. v. Alkem Labs. Ltd.
  Firvanq® (vancomycin)
  Defendant’s ANDA product does not infringe the “flavoring agent” claim limitation in light of the preamble’s “consisting of” language and plaintiff’s disclaimer during patent prosecution.
• Bristol-Myers Squibb Co. v. Xspray Pharma AB
  Sprycel®/Dasynoc® (dasatinib)
  The court denied a motion for judgment on the pleadings based on conflicting assertions in the NDA where the NDA was not specifically relied on in amended complaint.
• Purdue Pharma L.P. v. Accord Healthcare Inc.
  OxyContin® (oxycodone HCl)
  Abuse deterrence and purity patents were invalid as obvious when routine experimentation and common sense would motivate a skilled artisan to combine certain prior art references and have an expectation of success in achieving the claimed limitations.
• Bristol-Myers Squibb Co. v. Nanocopoeia, LLC
  Sprycel® (dasatinib)
  Because Defendant’s NDA did not directly address the issue of infringement, thereby raising disputes of material fact, judgment on the pleadings was denied.

Relevant ANDA Updates highlighted in this issue:

• ANDA Approvals
• ANDA Litigation Settlements
• Generic Launches
• New ANDA Cases